YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 182 drug applications between 26 March 2022 and 1 April 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 34, covering 29 drug names.
2022/03/26 – 2022/04/01
- New acceptances this week
- 182
- Drugs with new generic filings (by drug name, de-duplicated)
- 29
- Accepted this week, now under review
- 0
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
182filings, 34 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 99 |
| Generic | 34 |
| New drug | 27 |
| Import | 17 |
| Import re-registration | 3 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 133 |
| Therapeutic biologic | 28 |
| TCM | 19 |
| Prophylactic biologic | 2 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
29 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 2 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 3 | Sodium Thiosulfate Injection | 2 | 1 | 3 |
| 4 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 5 | Sodium Valproate Oral Solution | 1 | 1 | 1 |
| 6 | Carboprost Tromethamine Injection | 1 | 1 | 2 |
| 7 | Carbazochrome Sodium Sulfonate Injection | 1 | 1 | 1 |
| 8 | Salbutamol Sulfate Inhalation Solution | 1 | 1 | 2 |
| 9 | 噻托溴铵吸入粉雾剂 · No verified English name | 1 | 1 | 2 |
| 10 | Digoxin Injection | 1 | 1 | 3 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
121 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Pfizer Inc. | 6 | 4 | 0 |
| 2 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 3 | 0 |
| 3 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 4 | Anhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Genzyme Europe B.V. | 4 | 2 | 0 |
| 6 | A. Menarini GmbH | 4 | 1 | 0 |
| 7 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Ke Xing Biopharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Henan Run Hong Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Boehringer Ingelheim International GmbH | 3 | 1 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
47 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/04/01Import · Class 2.6 | 20价肺炎球菌多糖结合疫苗 · No verified English nameJXSL2200043 | Wyeth Pharmaceuticals LLC a subsidiary of Pfizer Inc.; Pfizer Investment CO Ltd. |
| 2022/04/01Import · Class 1 | 注射用PF-06730512 · No verified English nameJXSL2200042 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2022/04/01Import · Class 1 | BI685509片 · No verified English nameJXHL2200074 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2022/04/01Import · Class 1 | BI685509片 · No verified English nameJXHL2200073 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2022/04/01Import · Class 1 | BI685509片 · No verified English nameJXHL2200072 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2022/04/01Generic · Class 3 | Enalapril Maleate Oral SolutionCYHS2200518 | Chengdu Easton Biopharmaceuticals Co.,Ltd.; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2022/04/01Generic · Class 3 | Oliceridine Fumarate InjectionCYHS2200516 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2022/03/31Import · Class 2.2 | HL242吸入气雾剂 · No verified English nameJXHL2200079 | HAISCO HOLDINGS PTE. LTD.; Haisco Pharmaceutical Group Co. Ltd. |
| 2022/03/31Import · Class 2.2 | HL242吸入气雾剂 · No verified English nameJXHL2200078 | HAISCO HOLDINGS PTE. LTD.; Haisco Pharmaceutical Group Co. Ltd. |
| 2022/03/31Import · Class 2.2 | HL242吸入气雾剂 · No verified English nameJXHL2200077 | HAISCO HOLDINGS PTE. LTD.; Haisco Pharmaceutical Group Co. Ltd. |
| 2022/03/31Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2200513 | Hubei Xin Ze Fei Pharma Co., Ltd. romanized; Wuhan Hua Long Biopharmaceutical Co., Ltd. romanized |
| 2022/03/31Generic · Class 3 | Tranexamic Acid InjectionCYHS2200509 | Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Wu Zhou Tong Pharma Co., Ltd. romanized |
| 2022/03/31Generic · Class 3 | Tranexamic Acid InjectionCYHS2200508 | Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Wu Zhou Tong Pharma Co., Ltd. romanized |
| 2022/03/31New drug · Class 1 | 自体多抗原特异性细胞毒性T淋巴细胞注射液 · No verified English nameCXSL2200153 | Shenzhen Yi Shi Kang Ning Bio Technology Co., Ltd. romanized |
| 2022/03/31New drug · Class 1 | SH010注射液 · No verified English nameCXSL2200149 | Nanjing Sheng He Pharma Co., Ltd. romanized |
| 2022/03/31New drug · Class 1 | 注射用ZKLJ02 · No verified English nameCXHL2200207 | Yunnan Zhong Ke Long Jin Bio Technology Co., Ltd. romanized |
| 2022/03/31New drug · Class 2.3 | 注射用BH006 · No verified English nameCXHL2200206 | Zhuhai Bei Hai Bio Technology Co., Ltd. romanized |
| 2022/03/30Import · Class 2.2 | 肾上腺素鼻喷雾剂 · No verified English nameJXHL2200076 | ARS Pharmaceuticals Inc.; Pediatrix Therapeutics (Shanghai) Co. Ltd |
| 2022/03/30Import · Class 2.2 | 肾上腺素鼻喷雾剂 · No verified English nameJXHL2200075 | ARS Pharmaceuticals Inc.; Pediatrix Therapeutics (Shanghai) Co. Ltd |
| 2022/03/30Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2200503 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2022/03/30Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2200502 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2022/03/30New drug · Class 1 | AK104注射液 · No verified English nameCXSL2200134 | Kang Fang Pharma Co., Ltd. romanized |
| 2022/03/30New drug · Class 2.3 | 注射用H889A · No verified English nameCXHL2200205 | Hu Zhou Hui Zhong Ji Shi Bio Technology Co., Ltd. romanized |
| 2022/03/30New drug · Class 2.3 | 注射用H889A · No verified English nameCXHL2200204 | Hu Zhou Hui Zhong Ji Shi Bio Technology Co., Ltd. romanized |
| 2022/03/30New drug · Class 1 | WJ13404片 · No verified English nameCXHL2200203 | Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/03/30New drug · Class 1 | WJ13404片 · No verified English nameCXHL2200202 | Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/03/30New drug · Class 1 | Ceralasertib薄膜包衣片 · No verified English nameCXHL2200201 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
| 2022/03/30New drug · Class 1 | Ceralasertib薄膜包衣片 · No verified English nameCXHL2200200 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
| 2022/03/29Generic · Class 3 | Tirofiban Hydrochloride InjectionCYHS2200496 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/03/29New drug · Class 1.1 | 清达颗粒 · No verified English nameCXZL2200016 | Fujian Zhong Pharmaceuticals University romanized |
17 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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